WO2000076432A1 - Clip and applicator for tubal ligation - Google Patents

Clip and applicator for tubal ligation Download PDF

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Publication number
WO2000076432A1
WO2000076432A1 PCT/CA2000/000683 CA0000683W WO0076432A1 WO 2000076432 A1 WO2000076432 A1 WO 2000076432A1 CA 0000683 W CA0000683 W CA 0000683W WO 0076432 A1 WO0076432 A1 WO 0076432A1
Authority
WO
WIPO (PCT)
Prior art keywords
clip
applicator
jaws
sleeve
lower jaw
Prior art date
Application number
PCT/CA2000/000683
Other languages
French (fr)
Inventor
Mark Stafford Carey
Original Assignee
Mark Stafford Carey
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mark Stafford Carey filed Critical Mark Stafford Carey
Priority to AU53802/00A priority Critical patent/AU5380200A/en
Publication of WO2000076432A1 publication Critical patent/WO2000076432A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/202Means specially adapted for ligaturing, compressing or clamping of oviduct or vas deferens
    • A61F6/204Clamp applying devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/206Clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord

Definitions

  • This invention relates to a clip and laparoscopic clip applicator for tubal ligation
  • the invention relates to a method of performing the procedure.
  • the invention relates
  • Tubal ligation is a safe, effective, and common means of contraception for
  • rigid laparoscope which is a viewing device containing a light source and a
  • the operation may also be performed without the aid of an
  • endoscope by making a larger incision in a procedure commonly referred to as minilaparotomy. In both procedures, the patient's fallopian tubes are closed
  • the clip is hinged around a stainless steel pin and is held open by a U-shaped
  • the clip applicator to secure the clamp in the closed position.
  • the clip applicator is a
  • laparoscopic instrument adapted to receive the clip.
  • the improved clip and applicator according to the invention can be cost-
  • tubal ligation performed under local anesthesia, as well as reducing the use of
  • the device and method according to the invention provides an
  • the present invention relates to a clip and applicator for clamping a fallopian
  • the clip and applicator have complementary docking means for
  • the clip which has a forward end and a rear end, comprises an upper jaw and
  • the upper jaw and the lower jaw body each have a forward
  • the jaws are pivotally attached by means of a hinge and
  • upper jaw and lower jaw body operate to lock the clip in the third closed
  • the applicator comprises an elongate body over which a sleeve axially slides.
  • the sleeve covers a rear section of the lower jaw when the clip is in the open
  • the sleeve is adapted to push the jaws into the substantially closed
  • the sleeve is also
  • two slots are defined within the front end of the sleeve to
  • the invention also provides a method of closing a fallopian tube comprising the
  • Figure 1 A is an isometric view of the clip.
  • Figure 1 B is an isometric view of the clip from a direction opposite to
  • Figure 1C is an isometric view of the clip showing the front end of the clip in cross section.
  • Figure 2 is a cross sectional view of the applicator and clip.
  • Figure 3 is another cross sectional view of the applicator and clip showing the clip in a closed position.
  • Figure 4 is another cross section view of the applicator and clip showing the clip in a locked position.
  • Figure 5 is a view partly in section showing the applicator ready to be attached to the clip.
  • Figure 6 is a view partly in section showing the clip inserted into the applicator and being rotated.
  • Figure 7 is a view partly in section showing the clip secured within the applicator.
  • Figure 8 is an isometric view of the clip and applicator at the commencement of the closing sequence.
  • Figure 9 is an isometric view of the clip with the faceplate removed and the applicator showing the clip in the substantially closed position.
  • Figure 10 is an isometric view of the clip with the faceplate removed and the applicator showing the clip in the closed and locked position.
  • Figure 11 is a view partly in section of the underside of the concentric sleeve showing the key.
  • the clip 20 is comprised of an upper jaw 1
  • the upper jaw 1 attaches to the lower jaw body 3 by
  • a suitable biasing means is provided to cooperate with the hinge to upwardly bias the upper jaw 1 such that the clip 20 always tends
  • the clip 20 has a jaw
  • the hinge 2 is comprised of a pin member 4 which fits through corresponding
  • the pin 4 is made of titanium.
  • the pin is orientated
  • the upper jaw which is
  • the biasing means used to upwardly bias the upper jaw (not shown in
  • a resilient spring element may be selected from at least two options.
  • a resilient spring element may be selected from at least two options.
  • the resilient spring element may comprise, for example, an
  • the means for upwardly biasing the upper jaw may comprise some other resilient material located inside the intersection of the upper jaw 1
  • lower jaw body 3 as for example, silicon.
  • the outer surface of the lower jaw body 3 is generally smooth and rounded.
  • the top surface of the upper jaw 1 which is preferably made of titanium, is
  • Each of the upper jaw 1 and lower jaw body 3 have interior opposing
  • clamping surfaces 16A and 16B respectively which are generally flat and
  • the clip 20 has complementary locking
  • the clip has docking means 12 at its rear for
  • the complementary locking means consist firstly of a downwardly extending
  • locking element 4 formed integrally and located at the front end of upper jaw
  • the locking means consist of a receiving member 6 forming a
  • Figure 1 C which is a
  • cross sectional view of the front end of the clip shows the locking element 4
  • the locking element 4 is
  • locking element terminates at a sharp point 17 and is further comprised of two
  • Each protrusion 18 has an engagement surface and a locking surface.
  • each protrusion 18 is located at the top edge thereof and is
  • the locking surfaces abut the receiving member 6 to prevent the
  • the receiving member 6 is comprised of a
  • Each set of bars function to provide support and rigidity to the front
  • Each locking bar has an
  • each locking bar located on the inside surface thereof, is tapered inwardly at an
  • the locking element 4 is forced into
  • the locking element to be taken as the distance between the outer most edge
  • each protrusion is greater than the width of the space separating the upper
  • each protrusion 18 simultaneously exerts a greater outward force on its
  • the locking bars are flexed outwardly and
  • each protrusion has slid completely over and past its corresponding locking
  • protrusion catches and abuts against the locking surface of the locking bar
  • the docking means consist of a cam like docking tab
  • the docking means further include anti-rotation
  • the clip comprises a keyway 13 which is open at the rear as shown.
  • keyway 13 extends longitudinally along the underside of the lower jaw body
  • the applicator is now described.
  • the purpose of the applicator is to hold and
  • the applicator comprises a cylindrical core body 40
  • forward end of core body 40 has receiving means for the docking tab 12 and
  • the applicator body 40 is hollow at its
  • An end plate 41 is provided having an aperture 11
  • the clip may be attached to and
  • the telescoping concentric sleeve 10 has jaw
  • the telescoping concentric sleeve accordingly can be moved forwardly and
  • the key 50 on the applicator is in a position to engage and slide into the
  • the upper jaw 1 and lower jaw body 3 specifically
  • substantially closed position also assists in ensuring that the surgeon does
  • tactile feedback to the surgeon may be provided by means of an
  • An abutment provides a redundancy or
  • fallopian tube (not shown) is positioned between the inner clamping surfaces
  • protrusions pass completely through the locking bars and such that the
  • the clip 20 may now be disengaged from the applicator by rotating the core

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Reproductive Health (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)

Abstract

A clip and applicator for clamping a fallopian tube, and a method of carrying out the procedure. The clip has pivoting jaws which are adapted to pivot between a first open position where the jaws are apart, a second substantially closed position, and a third closed and locked position. The clip has means to bias the jaws towards the open position. Complementary locking means at the forward end of each jaw secure and lock the clip. The applicator comprises an elongate body over which a sleeve axially slides. The sleeve is adapted to move the jaws into the substantially closed position for insertion of the clip through the incision, and then to the closed and locked position to occlude the fallopian tube. The clip is removably attached to the applicator by docking means adapted to secure the forward end of the applicator body to the rear end of the clip.

Description

Title: CLIP AND APPLICATOR FOR TUBAL LIGATION
BACKGROUND OF THE INVENTION
Field of the Invention
This invention relates to a clip and laparoscopic clip applicator for tubal ligation,
and a method of performing the procedure. In particular, the invention relates
to a small profile clip to be inserted through a small incision in the abdominal
cavity of a patient in order to occlude the fallopian tubes, and to a method of
performing the procedure using the device.
Tubal ligation is a safe, effective, and common means of contraception for
women. The operation is now usually performed endoscopically using a small
rigid laparoscope which is a viewing device containing a light source and a
camera. A ligation clip and applicator or cautery device designed to occlude
the patient's fallopian tubes is used. Laparoscopic instruments are designed
to be inserted into the operative field through small incisions in the wall of the
abdomen. The operation may also be performed without the aid of an
endoscope by making a larger incision in a procedure commonly referred to as minilaparotomy. In both procedures, the patient's fallopian tubes are closed
using clips which are clamped in place using an applicator.
The prevalence of minimally invasive surgery has found applications in many
realms of surgical practice. In the case of tubal ligation, laparoscopic
sterilization has increased and minilaparotomy has decreased.
Laparoscopic sterilization results in a shorter less painful procedure and
decreased use of health care resources. However, some pain and nausea still
accompany the procedure. Recent studies have suggested that performing the
procedure under local anesthesia has medical benefits including avoiding the
costs and risks associated with a general anaesthetic. It also leads to a
quicker recovery time and less time spent in the hospital.
Importantly, known clips and applicators are not designed specifically to be
used with local anaesthetic due to their larger size .
Description of the Prior Art
Examples of prior art include Hulka et al. (US Patent No. 3,882,854) and Casey
etal. (US Patent No. 4,489,725). Hulka et al. (US Patent No. 3,882,854) discloses a surgical clip and applicator.
The clip is hinged around a stainless steel pin and is held open by a U-shaped
spring. When the target fallopian tube is positioned between the jaws of the
clip, the same spring is pushed over the top and bottom jaws of the clip by the
applicator to secure the clamp in the closed position. The clip applicator is a
laparoscopic instrument adapted to receive the clip.
Casey et al. (US Patent No. 4,489,725) discloses a surgical clip with two jaws
hinged by lugs extending from the upper jaw mating with corresponding
apertures in the lower jaw. The clip is closed by pressure from the applicator
which deforms the upper jaw causing it to lengthen and abut against a latching
portion of the lower jaw.
In the last several years, manufacturers have been able to miniaturize
endoscopic lenses for insertion into the abdomen through an incision no larger
than 2 - 4 mm in size. The prior art clips are too large to fit through such an
incision. Accordingly, there is a need for smaller clips and applicators
specifically designed for local anesthesia to realize the benefits of this type of
procedure. In addition, there is a small but significant failure rate for the prior art clips. The
most common reason for the failures is misapplication. Accordingly, there is
also a need for a method and an applicator which can reduce the potential for
operator error.
SUMMARY OF THE INVENTION
It is an object of the invention to provide an improved clip and applicator and a
method of performing a tubal ligation procedure using the clip and applicator.
The improved clip and applicator according to the invention can be cost-
effectively manufactured in a size small enough to fit through an incision 5 mm
or smaller, allowing it to take advantage of the new miniature endoscopic
lenses and making it particularly suitable for outpatient procedures performed
under local anesthesia. This allows the patient to experience the benefits of a
tubal ligation performed under local anesthesia, as well as reducing the use of
costly hospital resources.
Furthermore, the device and method according to the invention provides an
improved locking mechanism for the clip to reduce the potential for operator
error and reduce the risk of incomplete fallopian tube occlusion. The present invention relates to a clip and applicator for clamping a fallopian
tube. The clip and applicator have complementary docking means for
removably attaching one to the other.
The clip, which has a forward end and a rear end, comprises an upper jaw and
a lower jaw body. The upper jaw and the lower jaw body each have a forward
end and a rear end. The jaws are pivotally attached by means of a hinge and
are adapted to pivot between a first open position where the jaws are apart, a
second substantially closed position to minimize the profile or cross section of
the clip for insertion through a small incision, and a third locked position where
the jaws are pressed together to close the fallopian tube. Biasing means
cooperate with the hinge to bias the jaws to the open position, specifically by
means of upwardly locating and biasing the upper jaw with reference to the
lower jaw body. Complementary locking means at the forward ends of the
upper jaw and lower jaw body operate to lock the clip in the third closed and
locked position.
The applicator comprises an elongate body over which a sleeve axially slides.
The sleeve covers a rear section of the lower jaw when the clip is in the open
position. The sleeve is adapted to push the jaws into the substantially closed
position for insertion of the clip through the incision. The sleeve is also
configured to push the jaws into the closed positions and lock the jaws in the closed position by engaging the locking means thereby occluding the fallopian
tube. Preferably, two slots are defined within the front end of the sleeve to
accommodate the fallopian tube as the sleeve operates to close and lock the
clip.
The invention also provides a method of closing a fallopian tube comprising the
steps of:
(a) attaching the applicator to a clip;
(b) positioning the jaws of the clip in the substantially closed position
(c) inserting the clip in the substantially closed position into the
abdominal cavity through an incision;
(d) releasing the jaws of the clip in the open position when the clip is
inside the abdominal cavity;
(e) positioning the clip such that the fallopian tube is located between
the jaws of the clip;
(f) locking the jaws of the clip to clamp the fallopian tube;
(g) releasing the locked clip from the applicator; and
(h) withdrawing the applicator.
Further features of the invention will be described or will become apparent in
the course of the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS
In order that the invention may be more clearly understood, a preferred
embodiment thereof will now be described in detail by way of example, with
reference to the accompanying drawings, in which:
Figure 1 A is an isometric view of the clip.
Figure 1 B is an isometric view of the clip from a direction opposite to
Figure 1A.
Figure 1C is an isometric view of the clip showing the front end of the clip in cross section.
Figure 2 is a cross sectional view of the applicator and clip.
Figure 3 is another cross sectional view of the applicator and clip showing the clip in a closed position.
Figure 4 is another cross section view of the applicator and clip showing the clip in a locked position.
Figure 5 is a view partly in section showing the applicator ready to be attached to the clip.
Figure 6 is a view partly in section showing the clip inserted into the applicator and being rotated. Figure 7 is a view partly in section showing the clip secured within the applicator.
Figure 8 is an isometric view of the clip and applicator at the commencement of the closing sequence.
Figure 9 is an isometric view of the clip with the faceplate removed and the applicator showing the clip in the substantially closed position.
Figure 10 is an isometric view of the clip with the faceplate removed and the applicator showing the clip in the closed and locked position.
Figure 11 is a view partly in section of the underside of the concentric sleeve showing the key.
PREFERRED EMBODIMENT
To better describe the invention, the terms up, down, front and rear will be
used with reference to the clip. These directions are used as guides with
reference to the orientation of the clip as shown in Figure 1C.
Referring to Figures 1A and 1 B, the clip 20 is comprised of an upper jaw 1
and a lower jaw body 3. The upper jaw 1 attaches to the lower jaw body 3 by
means of a hinge 2. A suitable biasing means is provided to cooperate with the hinge to upwardly bias the upper jaw 1 such that the clip 20 always tends
to and remains in an open position. In the open position the clip 20 has a jaw
like profile.
The hinge 2 is comprised of a pin member 4 which fits through corresponding
apertures at the rear end of the upper jaw 1 and lower jaw body 3
respectively. Preferably, the pin 4 is made of titanium. The pin is orientated
transversely and fixedly secured within the corresponding apertures of the
lower jaw body by means of crimping the pin. The upper jaw, which is
pivotally secured to the lower jaw body by the pin, is able open and close with
reference to the lower jaw body 3. The ends of the pin are flush with the
lower jaw body of the clip such that the clip may be safely inserted into and
guided through the abdominal cavity.
The biasing means used to upwardly bias the upper jaw (not shown in
figures) may be selected from at least two options. A resilient spring element
located inside of the intersection of the upper jaw 1 and lower jaw body 3 may
be used. The resilient spring element may comprise, for example, an
integrally formed resilient arm extending diagonally upwards from the top
surface of the lower jaw body abutting the bottom surface of the upper jaw.
Alternatively, the means for upwardly biasing the upper jaw may comprise some other resilient material located inside the intersection of the upper jaw 1
and lower jaw body 3, as for example, silicon.
To close the upper jaw 1 , a downward force must be applied which is greater
than the upward force exerted by the upward biasing means. The biasing
means tends to force the upper jaw into the open position when the
downward force is removed. Substantial closure of the clip to minimize its
profile is necessary for insertion of the clip into the abdominal cavity through a
small incision. After insertion, the clip must be able to open inside the
abdominal cavity. The operation of the clip is described in greater detail later
in the specification.
The outer surface of the lower jaw body 3 is generally smooth and rounded.
The top surface of the upper jaw 1 , which is preferably made of titanium, is
flat. Each of the upper jaw 1 and lower jaw body 3 have interior opposing
clamping surfaces 16A and 16B respectively which are generally flat and
approximately 4 mm by 10 mm in dimension. During operation of the clip it is
the interior clamping surfaces which occlude the fallopian tube.
Referring now to Figures 1A and 1C, the clip 20 has complementary locking
means formed integrally adjacent its open ends which function to close and
lock the upper jaw 1 with reference to the lower jaw body 3 in a manner described hereinafter. As well, the clip has docking means 12 at its rear for
engagement with and removable attachment to an applicator used to
manipulate and install the clip as hereinafter described.
The complementary locking means consist firstly of a downwardly extending
locking element 4 formed integrally and located at the front end of upper jaw
1. Secondly, the locking means consist of a receiving member 6 forming a
cavity located at the front end of the lower jaw body 3 and formed integrally
therewith which receives the locking element to retain it within thereby locking
the upper jaw with reference to the lower jaw body. Figure 1 C, which is a
cross sectional view of the front end of the clip, shows the locking element 4
within the receiving member 6.
Referring to Figure 1A and in particular to Figure 1C, the locking element 4 is
located at the extreme forward end of the upper jaw 1 and extends
downwardly at substantially 90 degrees with reference to the upper jaw. The
locking element terminates at a sharp point 17 and is further comprised of two
outward protrusions18 located above the sharp point, one on each side
thereof. The sharp point aids in the closure and subsequent locking of the
clip by piercing a membrane attached to the fallopian tube. Each protrusion 18 has an engagement surface and a locking surface. The
engagement surface of each protrusion curves gently at its base and the
outside edge is tapered inwardly. The inward tapering of the protrusions
facilitates the insertion of the locking element 4 into the receiving member 6
and is described in greater detail later in the specification. The locking
surface of each protrusion 18 is located at the top edge thereof and is
outwardly perpendicular with reference to the body portion of the locking
element 4. The locking surfaces abut the receiving member 6 to prevent the
egress of the locking element 4 from the receiving member when the clip is in
the closed and locked position, which is hereinafter described.
Referring still to Figures 1A and 1 C, the receiving member 6 is comprised of a
faceplate 19 (removed in Figure 1C) located at the extreme front end of the
lower jaw body and two sets of bars, an upper set of locking bars 22 and a
lower set of supporting bars 23, which connect the faceplate to the lower jaw
body 3. Each set of bars function to provide support and rigidity to the front
end of the clip, and in particular to the receiving member. The locking bars 22
perform an additional function. Specifically, the upper set of locking bars
cooperate and engage with the protrusions 18 of the locking element 4 to lock
the clip in the closed and locked position. Each locking bar has an
engagement surface and a locking surface. The engagement surface of each locking bar, located on the inside surface thereof, is tapered inwardly at an
angle corresponding to the outer tapered edges of the protrusions.
During ligation of the fallopian tube, the locking element 4 is forced into
contact with the receiving member 6. More specifically, the engagement
surface of each protrusion 18 comes into contact with the engagement
surface of a corresponding resilient locking bar 22. The maximum width of
the locking element, to be taken as the distance between the outer most edge
of each protrusion, is greater than the width of the space separating the upper
locking bars. Therefore, as a greater downward force is applied to the upper
jaw 1 , each protrusion 18 simultaneously exerts a greater outward force on its
corresponding locking bar 22. The locking bars are flexed outwardly and
spread apart in response to the outward force. The flexing of each locking
bar is aided by the curved base and tapered outside edge of each protrusion,
permitting the protrusions to slide downwardly over the locking bars. Once
each protrusion has slid completely over and past its corresponding locking
bar, the outward force is no longer exerted. Each resilient locking bar then
automatically returns to its original unflexed configuration. The flat locking
surface of the protrusions prevent the egress of the locking element as each
protrusion catches and abuts against the locking surface of the locking bar it
engages. This operation describes the means by which the upper jaw is
locked to and secured to the lower jaw body of the clip. Referring to Figure 1 B, the docking means consist of a cam like docking tab
12 attached to the end of the clip by means of stem 14.
Referring to Figures 1 B and 2, the docking means further include anti-rotation
means located on the underside of the lower jaw body 3 of the clip which
engage complementary means on the applicator. The anti-rotation means on
the clip comprises a keyway 13 which is open at the rear as shown. The
keyway 13 extends longitudinally along the underside of the lower jaw body
ending with a stop 25 short of front end of the lower jaw body as better shown
in Figure 4. The function of the keyway will be later described.
The applicator is now described. The purpose of the applicator is to hold and
permit the clip to be manipulated by the surgeon during the tubal ligation
procedure.
Referring to Figures 2, 3 and 4, the operation of the applicator is described
with respect to the clip. The applicator comprises a cylindrical core body 40
and a telescoping concentric sleeve 10 external to the core body 40. The
forward end of core body 40 has receiving means for the docking tab 12 and
the telescoping sleeve 10 which when operated moves forwardly to close and
lock the clip around a fallopian tube. Referring now to Figures 5, 6 and 7, the applicator body 40 is hollow at its
front end defining a cavity. An end plate 41 is provided having an aperture 11
which communicates with the cavity. The shape of the aperture corresponds
to the shape of the docking tab 12. Thus the clip may be attached to and
secured within the applicator by means of insertion of the docking tab into the
aperture and rotation of the applicator body and end plate attached thereto
with reference to the clip an angular distance with sufficient to wedge and
secure the docking tab behind the end plate in the cavity.
Referring to Figures 8, 9 and 10, the telescoping concentric sleeve 10 has jaw
like cut out side openings 15 on each side corresponding in length to the
length of the clamping surfaces of the clip when attached to the applicator as
described. Referring to Figure 11 , the telescoping concentric sleeve 10 also
has a longitudinal key 50 located on the interior of the bottom sleeve which
aligns with and engages keyway 13 of the clip (shown in Figures 1 B and 2) to
prevent the rotation of the clip within and with reference to the applicator.
The telescoping concentric sleeve accordingly can be moved forwardly and
rearwardly relative to the forward end of the core body as described
hereinafter.
The tubal ligation method using the clip and applicator is now described. Referring to Figures 5, 6 and 7, the clip 20 is attached to and retained within
the cylindrical core body 40 of the applicator by insertion of the docking tab 12
into the aperture 11 on the cylindrical core body 40 which is rotated an
angular distance of 180 degrees with reference to the clip. This action
wedges and secures the cam like docking tab behind the end plate 41 and
prevents longitudinal separation of the clip from the applicator. Thus, the clip
is functionally and removably attached to the applicator and is aligned so that
the key 50 on the applicator is in a position to engage and slide into the
keyway 13 of the clip.
Referring to Figures 2 and 8, the telescoping concentric sleeve 10 is moved
forwardly over the clip. This step engages the key 50 within the keyway 13
located on the underside of the clip, and prevents any rotation of the clip with
reference to the applicator body. At this stage the clip is in the open position
and has a jaw like profile. The upper jaw 1 and lower jaw body 3, specifically
the clamping surface of each, are substantially apart.
Referring now to Figure 3, the forward movement of the concentric sleeve
now depresses downwardly the upper jaw 1 over the lower jaw body 3 of the
clip. This motion forces the upper jaw towards the lower jaw body. When the
locking element 4 comes into contact with the receiving member 6, the surgeon receives a tactile sensation, as the telescoping concentric sleeve no
longer slides easily over the clip. As described above, in order to lock the
clip, a pre-determined downward force must be exerted to overcome the
resistance provided by the locking bars 22. The tactile sensation of the
engagement surface of each protrusion 18 engaging its corresponding locking
bar indicates that the clip is in the substantially closed position for the purpose
of insertion into the abdominal cavity. A tactile indication that the clip is in the
substantially closed position also assists in ensuring that the surgeon does
not accidentally lock the clip, which operation is hereinafter described. It is
important to note that this closed orientation of the clip presents a minimum
forward profile or cross section, which is one of the important objects of the
invention.
Additionally, tactile feedback to the surgeon may be provided by means of an
abutment 26 located on the top surface of the upper jaw 1. Contact of the
front edge of the telescoping concentric sleeve 10 with the abutment 26
provides the surgeon with a tactile indication that the clip is in the
substantially closed position. An abutment provides a redundancy or
additional tactile indication that the clip is in the closed position to ensure that
the surgeon does not accidentally lock the clip. In the substantially closed position, as illustrated in Figure 3, the forward
profile or cross section of the clip 20 is minimized permitting insertion of the
clip and applicator which is attached thereto into the patient's abdominal
cavity through a small incision. No attempt is made here to describe any
particular surgical technique or procedure which a particular surgeon would
use. Rather the physical features of the applicator and clip and its operation
are sought to be described.
When the substantially closed clip has been inserted into the patient's
abdominal cavity, the surgeon, with the aid of a laparoscopic device, retracts
the telescoping concentric sleeve 10 which action permits the upper jaw 1 to
return to its preferred biased open position described above and shown in
Figures 2 and 8. The surgeon then positions the clip such that the targeted
fallopian tube (not shown) is positioned between the inner clamping surfaces
16A and 16B.
After the operator has positioned the targeted fallopian tube (not shown)
between the clamping surfaces 16A and 16B, the telescoping concentric
sleeve 10 is again moved forwardly over the upper jaw 1 and lower jaw body
3 of the clip. Once again, the surgeon receives the tactile sensation of the
locking element coming into contact with the receiving member, or sleeve 10
coming into contact with abutment 26, prior to locking the clip as described hereinafter. The side openings 15 on the telescoping concentric sleeves 10
provide clearance for the fallopian tube.
Referring to Figures 3 and 4, and also 9 and 10, the surgeon now moves the
telescoping concentric sleeve 10 forwardly, overcoming the resistance
provided by the locking bars and until the key 50 abuts against stop 25
located on the underside of the lower jaw body 3 of the clip. Figure 9 shows
the locking element within the receiving member, and specifically the locking
bars being forced outwards in response to the downward force applied to the
upper jaw. The leading edge of the telescoping concentric sleeve continues
to advance in a forward direction out over and past the locking element. As a
consequence, the locking element moves downwardly such that the
protrusions pass completely through the locking bars and such that the
locking surface of each protrusion engages the locking surface of its
corresponding locking bar as described in detail earlier in the specification,
and shown in Figures 4 and 10. This operation locks the upper jaw with
reference to the lower jaw body of the clip. The clip is now in a closed and
locked position and the fallopian tube is occluded.
The clip 20 may now be disengaged from the applicator by rotating the core
body 40 through an angular distance of 180 degrees in the opposite direction
such that the docking tab and aperture are once again in alignment, while holding the clip secure within the concentric sleeve 10 by means of the
keyway 13. This operation releases the docking means and permits the
applicator to be directly withdrawn from the abdominal cavity leaving the clip
attached to and occluding the fallopian tube.
From the foregoing, it will be seen that this invention is one well adapted to
attain all the ends and objects hereinabove set forth together with other
advantages which are obvious and which are inherent to the structure.
It will be understood that certain features and subcombinations are of utility
and may be employed without reference to other features and
subcombinations. This is contemplated by and is within the scope of the
claims.
Since many possible embodiments may be made of the invention without
departing from the scope thereof, it is to be understood that all matter herein
set forth or shown in the accompanying drawings is to be interpreted as
illustrative and not in a limiting sense.

Claims

CLAIMSHaving described the invention, what is claimed is:
1. A clip and applicator for clamping a fallopian tube:
(a) said clip and said applicator having complementary docking
means for removably attaching one to the other;
(b) said clip having a forward end and a rear end, said clip
comprising:
(i) a lower jaw body having a forward end and a rear end;
(ii) an upper jaw having a forward end and a rear end;
(iii) a hinge connecting said upper jaw to said lower jaw body;
said upper jaw adapted to pivot between a first open
position where said jaws are substantially apart, a second
substantially closed position where said jaws are closed
but not locked for insertion of the clip through an incision,
and a third closed and locked position;
(iv) biasing means attached to said lower jaw body to upwardly
locate and bias the upper jaw with reference to the lower
jaw body to said first open position;
(v) complementary locking means located at the forward ends
of said upper jaw and said lower jaw body, operable to close and lock said upper jaw in said third closed and
locked position;
(c) said applicator comprising:
(i) an elongate body having a forward end;
(ii) a sleeve on said elongate body operable to slide to engage
and move said upper jaw of said removably attached clip
to said first, second and third positions.
2. The invention as claimed in Claim 1 , wherein said complementary
locking means comprises: a locking member on one said forward end
consisting of a projection, said projection having an engaging surface at
the leading edge thereof and a locking surface rearward of said
engaging surface; and a receiving member on the other said forward
end consisting of a laterally resilient bar having an engaging surface
and locking surface; said engaging surface of said projection operating
to spreadingly engage said engaging surface of said resilient bar to
abut said locking surface on said projection against said locking surface
on said resilient bar thereby locking said locking member within said
receiving member.
3. The invention as claimed in Claim 2, wherein said hinge consists of pin
means connecting said rear end of said upper jaw to said lower jaw
body.
4. The invention as claimed in Claim 3, wherein said pin means is made
of titanium.
5. The invention as claimed in Claim 4, wherein said biasing means
comprises a quantity of resilient material attached to said lower jaw
body compressible in response to downward pivoting movement of said
upper jaw.
6. The invention as claimed in Claim 5, wherein said resilient material is
silicon.
7. The invention as claimed in Claim 4, wherein said biasing means is a
spring element attached to said lower jaw body compressible in
response to downward pivoting movement of said upper jaw.
8. The invention as claimed in Claim 7, wherein said spring element is a
resilient arm.
9. The invention as claimed in Claim 6 or 8, wherein said clip further
comprises an outer surface, said outer surface defining an abutment,
said abutment configured to position said sleeve in said substantially
closed position.
10. The invention as claimed in Claim 9, wherein said upper jaw is made of
titanium.
11. The invention as claimed in Claim 10, wherein said lower jaw body is
made from a plastic polypropylene material.
12. The invention as claimed in Claim 11 , wherein said complementary
docking means comprises: a cavity within said forward end of said
applicator body bounded by an end plate having a shaped aperture
therein; and a corresponding shaped projection attached to said rear
end of said lower jaw body of said clip; said clip being removably
attachable to said applicator by means of insertion of said projection
into said aperture and rotation thereof.
13. The invention as claimed in Claim 12, wherein said projection is a cam.
14. The invention as claimed in Claim 13, wherein said complementary
docking means further includes complementary anti-rotation means
consisting of means attached to said sleeve for engagement with
complementary means on said clip to prevent rotation of said clip with
reference to said applicator.
15. The invention as claimed in Claim 14, wherein said anti-rotation means
comprises: key means attached to said sleeve; a key way formed in
said lower jaw body; said key means engaging said key way to permit
axial movement of said sleeve with reference to said clip while
preventing rotational movement of said applicator body with reference
to said clip.
16. The invention as claimed in Claim 15, wherein said sleeve further
comprises an inner surface and an outer surface, and said key means comprises a rail projecting inwardly from said inner surface of said
sleeve.
17. The invention as claimed in Claim 16, wherein said key way comprises
a channel formed in said bottom surface of said lower jaw body.
18. The invention as claimed in Claim 17, wherein said rail is configured to
slidably engage said channel to prevent the rotation of said clip relative
to said applicator when said clip is attached to said applicator.
19. The invention as claimed in Claim 18, wherein said channel terminates
at a stop near said front end of said clip, said stop configured to prevent
further forward movement of said sleeve when said clip is in said
closed and locked position.
20. A method of closing a fallopian tube in an abdominal cavity of a patient
with a clip, the clip having two pivotally connected jaws biased in an
open position, the jaws configured to pivot between the open position, a
substantially closed position, and a locked closed position, the method
comprising the steps of:
(a) removably attaching an applicator to a clip;
(b) positioning the jaws of the clip in the substantially closed position;
(c) inserting the clip attached to the applicator through an incision
made in the abdominal cavity, the clip being positioned in the
substantially closed position; (d) releasing the jaws of the clip into the open position when the clip
is inside the abdominal cavity;
(e) positioning the clip such that the fallopian tube is located
between the jaws of the clip;
(f) locking the jaws of the clip to clamp the fallopian tube;
(g) releasing the locked clip from the applicator; and
(h) withdrawing the applicator.
21. A method of clamping a fallopian tube as defined in Claim 22 further
comprising the step of inserting an endoscopic camera into the incision
to assist the operator in locating the clip and carrying out the method.
22. A method of clamping a fallopian tube as defined in Claim 23, wherein
the applicator further comprises a body axially slidable within a sleeve.
23. A method of clamping a fallopian tube as defined in Claim 24, wherein
the clip is secured within the applicator in the substantially closed
position by sliding the sleeve forward over the jaws of the clip to move
them into the substantially closed position.
24. A method of clamping a fallopian tube as defined in Claim 25, wherein
the clip is released into the open position by pushing the clip attached
to the body, causing the sleeve to slide backward along the clip
allowing the jaws to be released into the open position.
5. A method of clamping a fallopian tube as defined in Claim 26, wherein
the clip is locked by sliding the sleeve forward over the jaws of the clip
to move them into the locked position.
PCT/CA2000/000683 1999-06-10 2000-06-09 Clip and applicator for tubal ligation WO2000076432A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU53802/00A AU5380200A (en) 1999-06-10 2000-06-09 Clip and applicator for tubal ligation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13854999P 1999-06-10 1999-06-10
US60/138,549 1999-06-10

Publications (1)

Publication Number Publication Date
WO2000076432A1 true WO2000076432A1 (en) 2000-12-21

Family

ID=22482531

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2000/000683 WO2000076432A1 (en) 1999-06-10 2000-06-09 Clip and applicator for tubal ligation

Country Status (2)

Country Link
AU (1) AU5380200A (en)
WO (1) WO2000076432A1 (en)

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US8529585B2 (en) 2010-01-29 2013-09-10 Advanced Bariatric Technology, Llc Surgical clamp and surgical clamp installation tool
US8920305B2 (en) 2007-01-19 2014-12-30 Advanced Bariatric Technology, Llc Vertically oriented band for stomach
US10420664B2 (en) 2014-08-26 2019-09-24 Advanced Bariatric Technology, Llc Bariatric clamp with suture portions, magnetic inserts and curvature
US10456141B2 (en) 2012-08-09 2019-10-29 Advanced Bariatric Technology, Llc Polymer overmolded bariatric clamp and method of installing
US10932938B2 (en) 2017-07-24 2021-03-02 Advanced Bariatric Technology, Llc Clamp installation tool
US11337839B2 (en) 2016-07-07 2022-05-24 Advanced Bariatric Technology, Llc Inflatable bariatric clamp
CN114533179A (en) * 2018-12-25 2022-05-27 奥林巴斯株式会社 Feeder and ligation device

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Publication number Priority date Publication date Assignee Title
US8920305B2 (en) 2007-01-19 2014-12-30 Advanced Bariatric Technology, Llc Vertically oriented band for stomach
US9814614B2 (en) 2007-01-19 2017-11-14 Advanced Bariatric Technology, Llc Vertically oriented band for stomach
US10369036B2 (en) 2007-01-19 2019-08-06 Advanced Bariatric Technology, Llc Vertically oriented band for stomach
US11938049B2 (en) 2007-01-19 2024-03-26 Advanced Bariatric Technology, Llc Vertically oriented band for stomach
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US8529585B2 (en) 2010-01-29 2013-09-10 Advanced Bariatric Technology, Llc Surgical clamp and surgical clamp installation tool
US10456141B2 (en) 2012-08-09 2019-10-29 Advanced Bariatric Technology, Llc Polymer overmolded bariatric clamp and method of installing
US11317924B2 (en) 2012-08-09 2022-05-03 Advanced Bariatric Technology, Llc Polymer overmolded bariatric clamp and method of installing
US12023039B2 (en) 2012-08-09 2024-07-02 Advanced Bariatric Technology, Llc Polymer overmolded bariatric clamp and method of installing
US11723786B2 (en) 2014-08-26 2023-08-15 Advanced Bariatric Technology, Llc Bariatric clamp with suture portions, magnetic inserts and curvature
US10420664B2 (en) 2014-08-26 2019-09-24 Advanced Bariatric Technology, Llc Bariatric clamp with suture portions, magnetic inserts and curvature
US11337839B2 (en) 2016-07-07 2022-05-24 Advanced Bariatric Technology, Llc Inflatable bariatric clamp
US10932938B2 (en) 2017-07-24 2021-03-02 Advanced Bariatric Technology, Llc Clamp installation tool
CN114533179A (en) * 2018-12-25 2022-05-27 奥林巴斯株式会社 Feeder and ligation device

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